To all who want to submit their reaction to the FDA / or want info on others who've had reactions

[Guest guest]

Anyone wanting to contact the FDA to submitt thier reaction from the affects of Miralax. Which is (Polyethylene Glycol) or any of the other names this drug is in, I'll just give you a few, generic name glyco-lax, NuLYTELY, GoLYTELY, Colyte, Colovage, Co-Lav, but the one most given as a laxative are Miralax and the generic form,Glyco-lax. If you feel you know someone has had an adverse reaction to this drug, please contact MedWatch at the FDA. ( 1-800-FDA-0178) If you have any questions or comments about the Med Watch program, they can be reached toll free at 1-800-FDA-1088 (press "0") This letter is dated March 5, 2002, I know they were moving some offices last year so some of these #'s might prompt you to call another #. You can double check by looking up Med Watch on the web. Koningstein is usually the one who records your information. If you want any adverse side affects that other people have submitted, you fax your request to : Food and

Drug Administration, Freedom of Information Act, 5600 Fishers Lane, Rockville, MD 20857 Note: The letter must state: I am requesting any adverse side affects (voluntary and mandatory) for the drug Miralax and or (Polyethylene Glycol) in pediatric and adult use. It must also state, that you are willing to pay any fee's applicable. It usually costs me $55.00. Depending on how many pages their are. In 2005, their were 447 submissions and the numbers are climbing thanks to this website. This process can take up to 3 months to receive but you will receive a letter of acknowledgement a couple weeks after submitting. This letter must be dated and signed, I recommend putting your phone # as well in case you missed something. Fax your request to 1- If any problems faxing call 1-. Once you receice your requests, you can request the individual reports, which are the actual submission the person wrote, ( example: My child was admitted to the

ER and was given etc.) You just need the report # to gain these records and submitt the same way asking for the Individual reports. You can also contact Hal Steppar's direct line @ 1-, He's the Paralegal Specialist Office of Regulatory Policy Division of Information Disclosure HFD-13. I petitioned the FDA in May, 2001 to take a look at the growing # of side affects and in 2002 they reponded, It needs more research. Please take part to heighten their awareness if this happened to you. Janet Woodcock, M.D. Director Center for Drug Evaluation and Research signed this letter. The letter states: I am writing to inform you that the Food and Drug Administration has not yet resolved the issues raised in your petition received on May, 18, 2001. Your petition requests that the Agency investigate the use of polyethylene glycol in children. FDA has been unable to reach a decision on your petition because it raises issues that require

additional review and analysis by the Agency. We will respond as soon as we have reached a decision on your request. If this med is suppose to be safe and not absorbed, then why are so many people complaining about the same issues on this group and if it's not absorbed and doesn't exist, then I shouldn't have even ONE submission from the FDA! Thank you to all the parent who've dedicated their time and patience to this cause our children are precious, Jeanie